Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 With Single, Escalating Doses in Healthy Subjects

A Randomised, Double-blind, Placebo-controlled, First Time-in-humans Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Escalating Doses of TA-8995 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01878474

Enrollment

Registered

2013-06-17

Start date

2008-03-31

Completion date

2009-06-30

Last updated

2013-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

MT-8995, Dyslipidemia, Cholesteryl ester transfer proteins

Brief summary

The purpose of this study is to assess the safety and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese volunteers.

Interventions

DRUGTA-8995

TA-8905 5, 10, 25, 50 (fasted and fed), 100 and 150 mg

DRUGPlacebo

Single ascending dose in Caucasian men

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Caucasian men aged 18-55 years and ≥65 years * Women of non-childbearing potential * Japanese men aged 18-55 years * Subjects were deemed healthy on the basis of medical history, physical examination, Electrocardiogram (ECG), vital signs and safety tests of blood and urine * Subjects were able to give fully informed written consent

Exclusion criteria

* HDL-C level ≥2.59 mmol/L * Abnormal Holter ECG * Family history of long QT syndrome, hypokalaemia or Torsade de Pointes * Vital signs or 12-lead ECG values outside the acceptable range * Positive tests for hepatitis B and C, HIV 1 and 2 * Positive urine pregnancy test (women only) * Severe adverse reaction or allergy to any drug * Drug or alcohol abuse * Smoking within the 6 months before dosing with TA-8995 (Caucasian subjects), or smoking more than 10 cigarettes daily (Japanese subjects) * Over-the-counter or prescribed medication up to 7 days or 5 half-lives (whichever was longer) before dosing with TA-8995 * Consuming food or drinks containing grapefruit or cranberry within the 7 days before dosing * Participation in other clinical trials, or loss of more than 450 mL blood within the previous 3 months * Clinically relevant abnormal findings at the screening assessment * Clinically relevant abnormal medical history or concurrent medical condition * Possibility that volunteer would not cooperate

Design outcomes

Primary

Measure	Time frame
Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)	336 hours post dose
Number of participants with adverse events	336 hours post dose
Laboratory tests (haematology, biochemistry and urinalysis)	336 hours post dose
Area under the concentration-time curve (mg/L・hr) up to 24 h (AUC0-24), 72 h (AUC0-72), 168 h (AUC0-168), 336 h (AUC0-336) and infinity (AUC0-∞) of TA-8995	336 hours post dose
Peak concentration (ng/mL) of TA-8995	336 hours post dose
Time of peak concentration (hr) of TA-8995	336 hours post dose

Secondary

Measure	Time frame
Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)	336 hours post dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026